Daniel Bednarik, Ph.D. – Professional Credentials

DANIEL BEDNARIK, PH.D.

13055 St. Patrick’s Ct. – Highland, MD 20777 – (443) 864.1445 – dbednarik@gmail.com

PROFILE:   EXECUTIVE * TRANSLATIONAL SCIENTIST * CONSULTANT

Accomplished and tenacious biopharmaceutical researcher and manager with extensive experience in leading the development of new clinical and research technologies and in guiding business and product development by new and established companies.

  • Genomics database design/implementation, bioinformatics tools development
  • Expert in infectious diseases – Virology, sepsis
  • Animal model development
  • Translational medicine – bench to bedside
  • Stratification of clinical trials using human biomarkers
  • FDA Advisory Committee participation/Regulatory Affairs
  • Experienced with writing/submitting IND/IDE/BLA/CMC regulatory documents
  • Co-Founder of Artesian Therapeutics, Inc. — Raised startup private equity funding ($5M)
  • Extensive consulting experience
  • Experienced with Dept. of Defense funding processes – DARPA/BARDA, recipient of $1.7M Phase-I DARPA contract (2006)

PROFESSIONAL EXPERIENCE (CHRONOLOGICAL)

INTREXON CORPORATION – GERMANTOWN, MD, 2012 (PRESENT)

Senior Director Operations, Molecular Engineering Unit (MEU) 2012

Provides molecular engineering support for the company’s programs and “External Channel Partner” collaborations in terms of proprietary gene design technology needs to facilitate drug and/or product development across a spectrum of corporate divisions and sectors. Works closely with the Chief Scientific Officer (MEU), President, Human Therapeutics Division (HTD), and the Cell Engineering Unit (CEU) to accelerate translation of technology to application in the clinic or other venues.

Key areas include:

  • Currently leads molecular operations for Intrexon Corp., overseeing 14 direct reports.
  • Construction and development of orally activated gene therapy solutions – Biologic, siRNA, cancer, and antiviral therapeutics.
  • Novel delivery of gene therapy solutions – viral, nonviral, nanoparticle.
  • Novel cell-based production platform development.
  • Veterinary, food science, health sector, bioinformatics, and other.

ABLITECH – BALTIMORE, MD 2012

A startup firm with a proprietary technology for delivering nucleic acid-based drugs, the firm has received approximately $2M in funding through a Department of Defense contract.

Director, Scientific Advisory Board

Assembled and presently lead an advisory board of recognized scientific experts to guide corporate goals and ensure scientific integrity. The board oversees multiple grant-funding initiatives and maximizes capitalization for forward-looking fiscal objectives and assists the CEO in identifying and enabling private equity investors. It also manages all translational application of the core technology and identifies appropriate corporate and academic partnerships.

CARDIOME PHARMA/ARTESIAN THERAPEUTICS – VANCOUVER, BC & GAITHERSBURG, MD 2002–2012

Cardiome Pharma is a research & development-based biopharmaceutical company dedicated to the discovery, development, and commercialization of new therapies focusing on the treatment of atrial fibrillation and heart failure with one product, Brinavess™ (Vernakalant IV) approved in Europe and elsewhere and multiple preclinical projects targeting areas of unmet medical need. In 2005, Cardiome acquired Artesian, which had co-developed and refined the proprietary Affymetrix GeneChip® database with Gene Logic, Inc. for heart failure drug discovery. Cardiome is presently also exploring the development of novel technologies for screening and testing of new antiviral molecules.

Head, Infectious Disease Pilot Program, 2011–2012

Conceived and developed a novel viral ion channel target program using synthetic biology approaches for the screening and testing of new, best-in-class antiviral molecules.Develop and implement a screening platform to identify novel inhibitors of the viroporins for Hepatitis C, Dengue Virus, and Influenza.

  • Determine the effectiveness of identified molecules to block the life cycles of HCV, Dengue, and Influenza viruses.
  • Implement strategy for validation, IND filing, and progression into the clinic.
  • Seek and execute new pharma partners for development of ion channel-based antivirals.

Director of Genomics & Bioinformatics, 2007–2012

Identified, recommended, and facilitated the integration of current and new bioinformatics and genomic technologies to assist in development and preclinical and clinical testing of the company’s pharmaceutical product pipeline. Designed biomarker strategies and complimentary animal models for early preclinical studies and worked with project teams to advance biomarker, genetic, and translational medicine study plans. Advanced project milestones with the goal of identifying individuals who do not respond to particular drugs.

  • Provided consultative medical and scientific advice in cardiovascular, infectious disease, and bioinformatics/genomics.
  • Introduced new bioinformatics approaches to strategically enhance drug-development success.
  • Identify potential biomarkers and efficacy surrogates for use in clinical trials and advise regarding the evolution of FDA and EMEA guidelines for the use of biomarkers.
  • Designed animal models for pre-clinical studies.

Consultant, Scientific Affairs, 2005–2007

Managed the post-acquisition drug program transition and integration of Artesian Therapeutics asset, and supported the design, molecular screening, and animal model testing of Artesian compound libraries.

  • Managed acquired BRPM and CRPM programs (Artesian) and managed chemistry, bioanalytical, toxicology, clinical, and regulatory program-planning components and deadlines.
  • Prepared program proposals for a new theranostic drug-development paradigm.

Vice President & Co-Founder, Cardiovascular Biology, Artesian Therapeutics, Inc., 2002–2005

Co-founded as a spinoff from Gene Logic (below) a company based on using of new gene-expression technology to determine gene-expression patterns in diseased tissue. Identified pivotal heart disease genes and translated findings to 3 led drug candidates for the treatment of heart failure. Established an in vitro analysis paradigm for drugs and validation paths for CRPM and BRPM Program small-molecule development for IND filing. Designed data-driven, animal-model studies for heart failure and cardiovascular disease.

  • Developed the proprietary Affumetrix GeneChip® database for heart failure drug discovery and patented more than 275 heart failure gene-expression profiles for diagnostics and therapeutics.
  • Raised $7M in venture capital (Oxford Bioscience Partners) and was instrumental in executing the VC partners’ exit strategy of finding a buyer (Cardiome) for the promising venture.

GENE LOGIC, INC. – GAITHERSBURG, MD 1997–2002

A company formed to exploit the sequencing of the human genome by comparing gene-expression patterns in diseased and normal tissues in multiple disease categories including cardiology, cancer, and psychiatric.

Scientific Director, Cardiovascular Database Product Development

Designed and deployed the largest known database for heart failure and vascular disease in collaboration with Proctor & Gamble, Temple University and Tufts University. Designed preclinical animal model studies for heart failure and cardiovascular disease to elucidate disease gene-expression profiles.

  • Translated gene-expression data into marketable information for subscription by multiple world-class pharmaceutical companies.
  • Secured collaborative human tissue-procurement and research alliances with major heart failure centers, hospitals, and universities worldwide.
  • Participated in the development of GeneChip®-based paradigms for data mining, drug discovery, development, and FDA approval.
  • Provided business- and product-development strategies to management and established relationships with 7 major pharmaceutical industry subscribers.

ADVANCED BIORESEARCH ASSOCIATES, ROCKVILLE, MD 1997

A regulatory consulting firm serving the pharmaceutical and medical device industries.

Director of Scientific Affairs

Performed due diligence of scientific and technical literature and prepared reports for IND submissions to the FDA and for corporate and venture partners of startup companies in these spaces. Served as a primary consultant for new product development to pharmaceutical and medical device companies.

HUMAN GENOME SCIENCES, INC. – ROCKVILLE, MD 1993–1997

A biopharmaceutical corporation founded in 1992, acquired by GSK in 2011 utilizes the human genome to develop protein and antibody drugs and, in partnership with other pharmaceutical companies, develop drugs to treat such diseases as hepatitis C, systemic lupus erythmatosis, anthrax, and cancer.

Senior Scientist

Identified, sequenced, and cloned novel human genes for the development of therapeutic proteins. Performed bioinformatics analysis on novel human genes, and prioritized gene selection for therapeutic development. Led the acquisition of all human tissues and sequencing of genes from those tissues. Supervised two technicians and was a key contributor to the development of one of the world’s largest bioinformatics databases.

  • Co-inventor on patents for 182 secreted proteins as therapeutic development candidates.
  • Identified and cloned novel seven-transmembrane receptors for development by GlaxoSmithKline (GSK).
  • Developed high-throughput biological validation assays for functional analysis of human genes, and pre-clinical animal models.

CENTERS FOR DISEASE CONTROL/EMORY UNIVERSITY – ATLANTA, GA 1989-1993

Section Chief, Molecular Genetics, Retrovirus Diseases Branch; Adjunct Professor, Emory University Winship Cancer Center & Dept. of Pathology [Please refer to Dr. Paul W. Doetsch as a credible reference for my history during this time]

  • Led 7 junior investigators to identify mechanisms of HIV/SIV pathobiology.
  • Participated in Biochemistry and Pathology teaching responsibilities (Emory)
  • Determined mechanisms of idiopathic cardiomyopathy (Heart Failure) induced by viral infection.

Additional Consulting Experience

• Immune Design Corp., Seattle, WA, 2011

• CD Diagnostics, Inc., Philadelphia, PA, 2010-2011

• Indel Therapeutics, Inc., Vancouver, BC, 2009-Present

• ProteiosBio LLC, Charlottesville, VA, 2011

• NX PharmaGen, Inc., Miami, FL, 2009-Present

• BioIT Solutions, Inc., Silver Spring, MD, 2012-Present

• Susavion Biosciences, Inc., Tempe, AZ, 2012

• Cardioxyl Pharmaceuticals, Inc., Towson, MD, 2007-2009

• ExonHit Therapeutics, Inc., Gaithersburg, MD, 2007-2009 (Consulting Director, Business Development)

• Bradmer Pharmaceuticals, Inc., Miami, FL 2006-2009

• Advanced Bionutrition (ABN), Columbia, MD, 2006

EDUCATION

THE JOHNS HOPKINS ONCOLOGY CENTER, THE JOHNS HOPKINS UNIVERSITY 1985–1989

Postdoctoral Fellow / Junior Faculty Member (Instructor)

Studied mechanisms of viral latency, and molecular mechanisms of interferon action. Participated in department programmatic development and teaching and authored multiple publications and book chapters.

  • Seminal discovery identifying DNA methylation as a mechanism for HIV disease latency and mechanisms of HIV activation by herpes simplex and cytomegalovirus.
  • Elucidated novel biological pathways for interferon-mediated inhibition of HIV transcription and assembly.
  • Developed novel recombinant gene therapy modalities for the inhibition of HIV transcription.

Temple University School of Medicine

Ph.D. in Biochemistry, 1985

M.S. in Biochemistry, 1982

Rider University

B.A. in Biology, 1980

GRANTS & CONTRACTS

  • Canadian Institutes of Health Research (CIHR). Co-Authour “A Novel Approach for the Discovery & Development of New Antiviral Therapeutics” (Awarded); Partnered Operations Grant Application – Cardiome Pharma Corp. & University of British Columbia (2012). Total $1,900,000 for 5 years.
  • DARPA BAA 06-31. “Crustacean Expression System for the Accelerated Manufacture of Pharmaceuticals.” 42 month term – $6.2M (2006) – Phase-I awarded (DTRA contract HDTRA1-07-C-0078 $1.7M Phase-I, Advanced BioNutrition Corp. (Consultant for ABN).
  • American Foundation for AIDS Research (AmFAR). Methylation as a Modulator of Expression of HIV. Research Grant #RG-000639 (1989-1991); Total direct costs $50,000; Total indirect costs $9,100.
  • The National Institutes of Health (NIH). Regulation of HIV La tency by Methylation of Proviral DNA. Young Investigator Award; #1-R29-AI-28567-01A1-ARR3 (1989). Total direct costs $350,000; Total indirect costs $224,686.

PUBLICATIONS, PATENTS, & ADDITIONAL BACKGROUND

Publications Link –> http://www.ncbi.nlm.nih.gov/pubmed/?term=Bednarik+D

Patents Link –> http://patentscope.wipo.int/search/rss.jsf?query=Bednarik%2C+Daniel&office=&rss=true&sortOption=Pub+Date+Desc

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